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510(k) DEN220040

Fibresolve by Imvaria, Inc. — Product Code QWO

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
January 12, 2024
Date Received
June 29, 2022
Clearance Type
Direct
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radiology Software For Referral Of Findings Related To Fibrotic Lung Disease.
Device Class
Class II
Regulation Number
892.2085
Review Panel
RA
Submission Type

Radiology software for referral of findings related to fibrotic lung disease is a prescription image processing device that analyzes computed tomography images to suggest the presence of disease or of an imaging finding suggestive of disease. The output of this device is intended to be used as adjunctive information as part of a referral pathway in the overall diagnostic assessment process.

Other clearances by Imvaria, Inc.

  • K252041 — Fibresolve (with PCCP) (November 7, 2025)
  • K241891 — ScreenDx (January 10, 2025)

Other clearances for product code QWO

  • K252041 — Fibresolve (with PCCP) (November 7, 2025)
  • K241891 — ScreenDx (January 10, 2025)
  • K242467 — IQ-UIP (December 19, 2024)